Sam Brusco, Associate Editor02.08.24
Biosense Webster, a Johnson & Johnson MedTech company, announced support for two collaborative studies of its Varipulse pulsed field ablation (PFA) platform, VIRTUE and POLARIS.
The two studies aim to better understand use and workflows of Varipulse to treat patients with diverse arrhythmias.
The study, which began in September 2023 and plans to enroll 150 subjects, is led by Vivek Reddy, MD, Director of Electrophysiology for the Mount Sinai Health System and The Helmsley Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai.
“The VIRTUE study is designed to understand how this pulsed field ablation (PFA) platform can be used to treat a variety of patients,” said Dr. Reddy. “The VARIPULSE Catheter and it’s integration with CARTO holds promise to be a versatile tool for physicians treating many types of patients with atrial arrhythmias.”
The study enrolled the first cases in December 2023, and plans to enroll 180 patients with paroxysmal AFib (PAF) and 180 patients with persistent AFib (Per AF) at four U.S. centers. The study is led by Moussa Mansour, MD, Director, Atrial Fibrillation Program; Jeremy Ruskin and Dan Starks Endowed Chair in Cardiology, Massachusetts General Hospital; and Professor of Medicine, Harvard Medical School.
“The POLARIS study includes both paroxysmal and persistent atrial fibrillation patients,” said Dr. Mansour. “Results of the study will add to the growing evidence that could point to PFA as the next generation technology for cardiac ablation.”
“Biosense Webster is pleased to collaborate on these studies to further understand the use of the VARIPULSE Platform for diverse anatomies and arrhythmia types,” added Jasmina Brooks, president of Biosense Webster. “We are committed to using multiple evidence generation approaches to lead the way in understanding PFA technology to inform future clinical practice.”
Earlier this week, Biosense Webster revealed 12-month results from its company-sponsored inspIRE study of the Varipulse PFA.
The two studies aim to better understand use and workflows of Varipulse to treat patients with diverse arrhythmias.
VIRTUE
The study is evaluating Varipulse’s use in a variety of atrial arrhythmias, including atrial fibrillation (AFib) and atypical atrial flutter (AFL), either as first-time or redo procedures.The study, which began in September 2023 and plans to enroll 150 subjects, is led by Vivek Reddy, MD, Director of Electrophysiology for the Mount Sinai Health System and The Helmsley Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai.
“The VIRTUE study is designed to understand how this pulsed field ablation (PFA) platform can be used to treat a variety of patients,” said Dr. Reddy. “The VARIPULSE Catheter and it’s integration with CARTO holds promise to be a versatile tool for physicians treating many types of patients with atrial arrhythmias.”
POLARIS
The second study is evaluating use and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior left atrial wall ablation using Varipulse.The study enrolled the first cases in December 2023, and plans to enroll 180 patients with paroxysmal AFib (PAF) and 180 patients with persistent AFib (Per AF) at four U.S. centers. The study is led by Moussa Mansour, MD, Director, Atrial Fibrillation Program; Jeremy Ruskin and Dan Starks Endowed Chair in Cardiology, Massachusetts General Hospital; and Professor of Medicine, Harvard Medical School.
“The POLARIS study includes both paroxysmal and persistent atrial fibrillation patients,” said Dr. Mansour. “Results of the study will add to the growing evidence that could point to PFA as the next generation technology for cardiac ablation.”
“Biosense Webster is pleased to collaborate on these studies to further understand the use of the VARIPULSE Platform for diverse anatomies and arrhythmia types,” added Jasmina Brooks, president of Biosense Webster. “We are committed to using multiple evidence generation approaches to lead the way in understanding PFA technology to inform future clinical practice.”
Earlier this week, Biosense Webster revealed 12-month results from its company-sponsored inspIRE study of the Varipulse PFA.